Mouthpiece for athletic performance enhancement

ABSTRACT

A bio-facilitation mouthpiece correlates a custom made mouthpiece with nervous system channeling to facilitate optimal physiologic activity. The mouthpiece may include right and lateral engagement portions having a top portion and a bottom portion. The top and bottom portions are adapted to include a plurality of surface impressions that correspond to the user&#39;s posterior teeth. A forward portion extends between the right and lateral engagement portions. A right outer flange member is coupled to the right lateral engagement portion, and a left outer flange member coupled to the left lateral engagement portion. At least a portion of the top portion and bottom portion of comprises a first material, and at least a portion of each of the forward portion, the right flange member, and the left flange member comprise a second material.

FIELD OF THE DISCLOSURE

This disclosure relates generally to dentistry, and, more particularly, to a custom-fitted athletic mouthpiece and a method of making said mouthpiece.

BACKGROUND

There are numerous mouthpieces that claim to enhance performance. The operative concept is that by enhancing muscle strength they can increase performance. The problem is that an oral appliance cannot increase muscle strength. Doctors can tell when a muscle is functioning at optimal levels and posturally position muscles to function at optimal levels but they cannot make the muscles stronger with a mouthpiece nor does increased strength necessarily reflect performance.

There is a complex interrelationship between breathing, head posture, tongue function, swallowing, the position of the teeth in the mouth and where they touch in function. Placing any device in the mouth changes the tongue posture, the shape of the airway, and the posture of the head on the spinal column. Oral appliances placed in the maxilla, especially those that contact the palate, take up space for the tongue, cause a lowered and retruded tongue position, reduce airway patency, and alter normal swallow.

Typical oral appliances used to enhance performance often extend entirely across the upper and lower dental arches. The resultant blocking of the anterior region of the mouth prevents a user from drinking liquids while wearing the oral appliance and also interferes with the user's ability to speak clearly and breathe easily while wearing the oral appliance. In addition, such oral appliances are bulky and uncomfortable, and users typically remove the oral appliances as often as practical. In oral appliances that have a reduced thickness or employing certain design characteristics to allow for greater ease of speaking and/or breathing while wearing the appliance, trauma protection to the face is reduced and concussions resulting from the upper portion of the mandible contacting the brain may result. Moreover, typical oral appliances are fabricated in a laboratory or at a specialized facility, and such oral appliances are expensive to produce and also involve a significant amount of fabrication time.

Accordingly, there is a need for a performance enhancing mouthpiece that allows physiologic and neurologic function at optimal levels while also being comfortable and simple to fabricate, being relatively inexpensive and fast to fabricate, while protecting the user from concussions and allowing a user to drink liquids, breathe easily, and speak clearly with the mouthpiece inserted.

BRIEF SUMMARY OF THE DISCLOSURE

In accordance with one exemplary aspect of the present invention, a bio-facilitation mouthpiece adapted to facilitate optimal neurological function includes an elongated right lateral engagement portion having a first end and a second end opposite the first end. The right lateral engagement portion has a top portion and a bottom portion, and the top portion is to include a plurality of surface impressions that correspond to the size and shape of a bottom portion of one or more of the user's upper right posterior teeth and the bottom portion adapted to include a plurality of surface impressions that correspond to the size and shape of a top portion of one or more of the user's lower right posterior teeth. The bio-facilitation mouthpiece also includes an elongated left lateral engagement portion having a first end and a second end opposite the first end. The left lateral engagement portion has a top portion and a bottom portion, the top portion is adapted to include a plurality of surface impressions that correspond to the size and shape of a bottom portion of one or more of the user's upper left posterior teeth and the bottom portion adapted to include a plurality of surface impressions that correspond to the size and shape of a top portion of one or more of the user's lower left posterior teeth. The bio-facilitation mouthpiece further includes a forward portion having a first end disposed adjacent to the first end of the right lateral engagement portion and a second end disposed adjacent to the first end of the left lateral engagement portion. The forward portion includes an upper edge disposed adjacent to a top edge of one or more of the user's lower anterior teeth such that a vertical gap exists between the upper edge and a bottom edge of each of the user's upper central incisors, with the vertical gap adapted to facilitate breathing and talking. The bio-facilitation mouthpiece additionally includes a right outer flange member coupled to the right lateral engagement portion and a left outer flange member coupled to the left lateral engagement portion. At least a portion of the top portion and bottom portion of each the right lateral engagement portion and left lateral engagement portion comprises a first material, and at least a portion of each of the forward portion, the right outer flange member, and the left outer flange member comprise a second material, and the first material has one or more physical properties that are different than one or more corresponding physical properties of the second material.

In accordance with another exemplary aspect of the present invention, a method of fabricating a bio-facilitation mouthpiece for a user includes identifying a user's maxillomandibular position of minimal nociceptive input and creating an impression of a portion of the user's upper and lower anterior teeth in the position of minimal nociceptive input and maximal neurological facilitation in a first material of a bio-facilitation mouthpiece that is comprised of both the first material and a second material. The first material has a lower melting temperature than the second material, and the user's maxillomandibular position of minimal nociceptive input and maximal neurological facilitation is maintained by the bio-facilitation mouthpiece when the user wears the bio-facilitation mouthpiece.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective top view of an embodiment of a bio-facilitation mouthpiece;

FIG. 2 is a top view of the embodiment of FIG. 1;

FIG. 3 is a left side view of the embodiment of FIG. 1 disposed in a user's mouth;

FIG. 4 is a cross-sectional view taken along section line 4-4 of FIG. 3;

FIG. 5 is a left side view of the embodiment of FIG. 1;

FIG. 6 is a left side view of the embodiment of FIG. 1 disposed in a user's mouth with an upper component disposed over the user's upper teeth;

FIG. 7 is a perspective top view of an embodiment of an upper component;

FIG. 8 is a front view of the embodiment of FIG. 1 disposed in a user's mouth with an upper component disposed over the user's upper teeth;

FIG. 9 is a rear view of the embodiment of FIG. 1 disposed in a user's mouth with an upper component disposed over the user's upper teeth;

FIG. 10 is a front view of the embodiment of FIG. 1 without the upper component;

FIG. 11 is a perspective view of upper and lower casts mounted to an articulator;

FIG. 12 is a perspective view of a first mold half and a second mold half with a cavity formed in each mold half;

FIG. 13 is a right side view of the embodiment of FIG. 1 disposed in a user's mouth;

FIG. 14A is a perspective view of an embodiment of a bite position assembly;

FIG. 14B is a plan view of the embodiment of the bite position assembly of FIG. 14A;

FIG. 14C is a section view taken along line A-A of FIG. 14B;

FIG. 14D is a partial plan view of the embodiment of a head portion of a bite member of the bite position assembly of FIG. 14A;

FIG. 14E is a section view taken along line 14E-14E of FIG. 14D;

FIG. 14F is a section view taken along line 14E-14E of an alternative embodiment of FIG. 14D;

FIG. 15A is a top view of an embodiment of a bio-facilitation mouthpiece;

FIG. 15B is a front view of the embodiment of the bio-facilitation mouthpiece of FIG. 15A;

FIG. 15C is a bottom view of the embodiment of the bio-facilitation mouthpiece of FIG. 15A;

FIG. 15D is a section view taken along line B-B of FIG. 15C;

FIG. 15E is a side view of the embodiment of the bio-facilitation mouthpiece of FIG. 15A;

FIG. 15F is a section view taken along line A-A of FIG. 15B;

FIG. 15G is a top view of an embodiment of a bio-facilitation mouthpiece that has surface impressions of a user's upper teeth;

FIG. 15H is a bottom view of an embodiment of a bio-facilitation mouthpiece that has surface impressions for a user's bottom teeth;

FIG. 15I is a section view taken along line C-C of FIG. 15A;

FIG. 15J is a section view taken along line D-D of FIG. 15A;

FIG. 15K is a perspective view of the embodiment of the bio-facilitation mouthpiece of FIG. 15A;

FIG. 15L is a partial perspective view of an the embodiment of a right outer flange member of a bio-facilitation mouthpiece;

FIG. 15M is a partial perspective view of an the embodiment of a forward portion of a bio-facilitation mouthpiece;

FIG. 15N is a side view of the right inner flange member taken along line E-E of FIG. 15A; and

FIG. 16 is a perspective view of the embodiment of the bio-facilitation mouthpiece of FIG. 15A that is secured to a model of an upper and lower set of teeth.

DETAILED DESCRIPTION

The disclosed bio-facilitation mouthpiece correlates a flexible, custom made mouthpiece with nervous system channeling to facilitate optimal physiologic and neurologic activity. A method and device is provided for registering the appropriate head, mouth, pharyngeal and body posture to facilitate optimal performance of physiologic and neurologic movement, biomechanical balance, range of motion and airway patency for human beings. A custom laboratory fabricated mouthpiece is provided to establish this position of bio-neurologic facilitation.

An embodiment of such a bio-facilitation mouthpiece 10 is illustrated in FIGS. 1 to 6 and 8 to 10, and the bio-facilitation mouthpiece 10 includes a base member 12, a right flange member 14 a, and a left flange member 14 b. The bio-facilitation mouthpiece 10 may be a single, unitary part made from a flexible, resilient material. As illustrated in FIGS. 1 and 2, the base member 12 is adapted to receive portions of a user's upper and lower teeth, and the base member 12 includes an elongated right lateral engagement portion 16 a having a first end 18 a and a second end 20 a opposite the first end 18 a. As illustrated in FIGS. 1, 2, and 4, the right lateral engagement portion 16 a has a top portion 22 a and a bottom portion 24 a, the top portion 16 a including a plurality of surface impressions 26 a that correspond to the size and shape of a bottom portion of one or more of the user's upper right posterior teeth. The bottom portion 24 a includes a plurality of surface impressions 27 a that correspond to the size and shape of a top portion of one or more of the user's lower right posterior teeth. The base member 12 also includes an elongated left lateral engagement portion 16 b having a first end 18 b and a second end 20 b opposite the first end 18 b, the left lateral engagement portion 16 b having a top portion 22 b and a bottom portion 24 b, the top portion 22 b including a plurality of surface impressions 26 b that correspond to the size and shape of a bottom portion of one or more of the user's upper left posterior teeth. The bottom portion 24 b includes a plurality of surface impressions 27 b that correspond to the size and shape of a top portion of one or more of the user's lower left posterior teeth.

Referring to FIGS. 1 and 2, the base member 12 further includes an arch-shaped forward portion 28 having a first end 30 disposed adjacent to the first end 18 a of the right lateral engagement portion 16 a and a second end 32 disposed adjacent to the first end 18 b of the left lateral engagement portion 16 b such that the forward portion 28, the right lateral engagement portion 16 a, and the left lateral engagement portion 16 b has a U-shape when viewed along a vertical axis. As illustrated in FIG. 3, the forward portion 28 includes a top surface 60 disposed adjacent to a top edge of one or more of the user's lower anterior teeth 122 such that a vertical gap G exists between the top surface 60 and a bottom edge of each of the user's upper central incisors 62. As illustrated in FIGS. 1, 2, 4, and 5, the base member 12 additionally includes a skirt portion 34 downwardly extending from each of the forward portion 28, the right lateral engagement portion 16 a, and the left lateral engagement portion 16 b. The skirt portion 34 has an inside surface 36 and an outside surface 38, and the outside surface 38 generally conforms in shape to an inside surface of a plurality of lower teeth of the user and an upper portion of the lower gum line of the user. As illustrated in FIG. 4, the surface impressions 26 a, 26 b of the top portions 22 a, 22 b of each of the right lateral engagement portion 16 a and the left lateral engagement portion 16 b are vertically spaced from the surface impressions 27 a, 27 b of the bottom portion 24 a, 24 b of the right lateral engagement portion 16 a and the left lateral engagement portion 16 by a distance of at least 2 mm to absorb an upward impact force on the user's mandible in a manner that prevents concussions. As illustrated in FIGS. 1 and 2, the bio-facilitation mouthpiece 10 also includes a right flange member 14 a coupled to the base member 12 adjacent to the right lateral engagement portion 16 a and a left flange member 14 b coupled to the base member 12 adjacent to the left lateral engagement portion 16 b.

Configured as described, the bio-facilitation mouthpiece 10 provides an open anterior portion (illustrated in FIG. 3) that allows the user to drink liquids while wearing the bio-facilitation mouthpiece 10. The open anterior portion also allows the user to talk and breathe comfortably and clearly, eliminating the need for the user to frequently remove the bio-facilitation mouthpiece 10 while participating in athletic activities. The bio-facilitation mouthpiece 10 also has a relatively small size that increases tongue space in the user's mouth to allow the user to speak more clearly with the bio-facilitation mouthpiece 10 inserted. Moreover, the bio-facilitation mouthpiece 10 enhances athletic performance by facilitating optimal neurological function because it maintains an optimal maxillomandibular relationship that minimizes nociceptive input (or maximal neurological bio-facilitation). The bio-facilitation mouthpiece 10 also provides protection against concussions. In addition, the bio-facilitation mouthpiece 10 may have profound effects on such a diverse and wide range of human physiologic functions or dysfunctions as TMJ pain, headaches, neck pain, daytime airway patency. Additionally, the bio-facilitation mouthpiece 10 may treat certain movement disorders, enhance isometric posture, head balance, and athletic performance by reducing nociceptive neurological interference.

Turning to the detailed structure of the bio-facilitation mouthpiece 10 illustrated in FIGS. 1 to 4, the bio-facilitation mouthpiece 10 includes a base member 12 that may be adapted to receive portions of a user's upper 40 and lower teeth 42, and the base member 12 may include the right lateral engagement portion 16 a and the left lateral engagement portion 16 b. The right lateral engagement portion 16 a may include the top portion 22 a and the bottom portion 24 a, and the top portion 22 a may include a plurality of surface impressions 26 a that correspond to the size and shape of a bottom portion of one or more of the user's upper right posterior teeth 44 a. For example, the top portion of the right lateral engagement portion may include a plurality of surface impressions that correspond to a bottom portion of each of the user's upper right third molar, the upper right second molar, the upper right first molar, the upper right second premolar, and the upper right first premolar. The bottom portion 24 a of the right lateral engagement portion 16 a may be disposed opposite the top portion 22 a, and the bottom portion 24 a may include a plurality of surface impressions 27 a that correspond to the size and shape of a bottom portion of one or more of the user's lower right posterior teeth 46 a. For example, the bottom portion of the right lateral engagement portion 16 a may include a plurality of surface impressions 26 a that correspond to a bottom portion of each of the user's lower right third molar, the lower right second molar, the lower right first molar, the lower right second premolar, and the lower right first premolar.

The right lateral engagement portion 16 a may have any suitable shape that accommodates the desired number of surface impressions 26 a. For example, the right lateral engagement portion 16 a may be elongated and may have a slightly curved shape when viewed along a vertical axis (i.e., the Z-axis provided in the reference coordinate system of FIG. 1) such that the right lateral engagement portion 16 a generally conforms to the shape collectively formed by the upper and lower right posterior teeth 44 a, 46 a (i.e., the molars and premolars) when viewed along a vertical axis. The right lateral engagement portion 16 a may be generally elongated along a longitudinally extending line L (illustrated in FIG. 2) generally disposed in a plane normal to the vertical axis, and the line L may be slightly curved to correspond to the general shape of an axis of symmetry that longitudinally bisects the upper and/or lower right posterior teeth 44 a, 46 a when viewed along a vertical axis. The elongated right lateral engagement portion 16 a may have the first end 18 a and the second end 20 a opposite the first end 18 a. The first end 18 a may be disposed at or adjacent to a surface impression 26 a that corresponds to the first or second premolars, and the second end 20 a may be disposed at or adjacent to a surface impression 26 a that corresponds to the first or second molars. The right lateral engagement portion 16 a may have any suitable width that allows the surface impressions 26 a, 27 a to be formed on each of the top portion 22 a and the bottom portion 24 a. For example, an area of the top portion 22 a that extends longitudinally along an inside edge 48 a of the top portion 22 a may be free from surface impressions, and/or an area of the top portion 22 a that extends longitudinally along an outside edge 50 a of the top portion 22 a may be free from surface impressions. In addition (or alternatively), an area of the bottom portion 24 a that extends longitudinally along an inside edge 52 a of the bottom portion 24 a may be free from surface impressions, and/or an area of the bottom portion 24 a that extends longitudinally along an outside edge 54 a of the bottom portion 24 a may be free from surface impressions. Alternatively, the surface impressions on the top portion 22 a and/or the bottom portion 24 a may extend to the inside edge 48 a, 52 a and/or the outside edge 50 a, 54 a such that no longitudinal space exists.

FIG. 4 illustrates a cross-section of the right lateral engagement portion 16 a that is normal to the line L of FIG. 2. In such a cross-section, the right lateral engagement portion 16 a may have a generally elongated shape extending generally along or parallel to the X-axis of the reference coordinate system of FIG. 1. The top portion 22 a and the surface that defines the surface impressions 26 a in the top portion 22 a may define an upper boundary of the elongated cross-sectional shape, thereby giving the upper boundary an irregular and generally contoured shape. Similarly, the bottom portion 24 a and the surface that defines the surface impressions 27 a in the bottom portion 24 a define a lower boundary of the elongated cross-sectional shape, thereby giving the lower boundary an irregular and generally contoured shape. The surface impressions 26 a formed on the top portion 22 a and the surface impressions 27 a formed on the bottom portion 24 a may be vertically (i.e., along or parallel to the Z-axis provided in the reference coordinate system of FIG. 1) separated by a minimum distance D to allow the resilient material comprising the mouthpiece to absorb an upward impact force on the user's mandible. The minimum distance D corresponds to the vertical distance between the lowermost (i.e., the portion of the surface impressions closest to the X-axis in the provided reference coordinate system of FIG. 4) portion of the surface impressions 26 a of the top portion 22 a and the uppermost (i.e., the portion of the surface impressions closest to the X-axis in the provided reference coordinate system of FIG. 4) portion of the surface impressions 27 a of the bottom portion 24 a. The absorption of such an upward blow by the material between the surface impressions 26 a formed on the top portion 22 a and the surface impressions 27 a formed on the bottom portion 24 a may prevent a rear portion of the user's mandible from perforating the brain, thereby preventing a concussion. The minimum distance D may be at least about 3 mm, and may be between about 3 mm and about 8 mm. Preferably, the minimum distance D may be between about 4 mm and 5 mm.

As discussed above and as illustrated in FIGS. 1 to 3, the base member 12 may also include the left lateral engagement portion 16 b. The left lateral engagement portion 16 b may be a mirror-image (i.e., may be symmetrical or generally symmetrical about a central axis C that is parallel to or collinear with the Y-axis of the reference coordinate system provided in FIG. 1) of the right lateral engagement portion 16 a described above, but the left lateral engagement portion 16 b may be adapted to receive a bottom portion of one or more of the user's upper left posterior teeth 44 b and lower left posterior teeth 46 b. Specifically, the left lateral engagement portion 16 b has the top portion 22 b and the bottom portion 24 b, and the top portion 22 b includes a plurality of surface impressions 26 b that correspond to the size and shape of a bottom portion of one or more of the user's upper left posterior teeth 44 b. For example, the top portion 22 b of the left lateral engagement portion 16 b may include a plurality of surface impressions 26 b that correspond to upper left third molar, the upper left second molar, the upper left first molar, the upper left second premolar, and the upper left first premolar. The bottom portion 24 b of the left lateral engagement portion 16 b may be disposed opposite the top portion 22 b, and the bottom portion 24 b includes a plurality of surface impressions 27 b that correspond to the size and shape of a bottom portion of one or more of the user's lower left posterior teeth 46 b. For example, the bottom portion 24 b of the left lateral engagement portion 16 b may include a plurality of surface impressions 27 b that correspond to the lower left third molar, the lower left second molar, the lower left first molar, the lower left second premolar, and the lower left first premolar.

The left lateral engagement portion 16 b may have any suitable shape that accommodates the desired number of surface impressions. For example, the left lateral engagement portion may be elongated and may have a slightly curved shape when viewed along a vertical axis such that the left lateral engagement portion 16 b generally conforms to the shape collectively formed by the upper and lower left posterior teeth 44 b, 46 b when viewed along a vertical axis. The elongated left lateral engagement portion 16 b may include the first end 18 b and the second end 20 b opposite the first end 18 b. The first end 18 b may be disposed at or adjacent to a surface impression that corresponds to the first or second premolars, and the second end may be disposed at or adjacent to a surface impression that corresponds to the first or second molars. The left lateral engagement portion 16 b may have any suitable width that allows the surface impressions to be formed on each of the top portion 22 b and the bottom portion 24 b, as explained in the discussion of the right lateral engagement portion 16 a. The left lateral engagement portion 16 b may have a cross-sectional shape that is a mirror image of the cross-section of right lateral engagement portion 16 a illustrated in FIG. 4. As explained in the discussion of the right lateral engagement portion 16 a, the surface impressions 26 b formed on the top portion 22 b and the surface impressions 27 b formed on the bottom portion 24 b may be vertically separated by a minimum distance D to allow the resilient material comprising the mouthpiece to absorb an upward impact force on the user's mandible. The minimum distance D may be at least about 3 mm, and may be between about 3 mm and about 8 mm. Preferably, the minimum distance D may be between about 4 mm and 5 mm.

As illustrated in FIGS. 1 to 3, 5, 8, 9 and 10, the base member may also include a forward portion 28 that may have the general shape of an arch when viewed parallel to or along a vertical axis (the Z-axis of the reference coordinate system of FIG. 1). The forward portion 28 may include the first end 30 disposed at or adjacent to the first end 18 a of the right lateral engagement portion 16 a and the second end 32 disposed at or adjacent to the first end 18 b of the left lateral engagement portion 16 b. So disposed, the forward portion 28, the right lateral engagement portion 16 a, and the left lateral engagement portion 16 b may have a U-shape when viewed parallel to or along a vertical axis. A forward edge 56 of the forward portion 28 may be contoured to correspond to the shape of the interior surface of a user's lower posterior teeth 58. More specifically, the forward edge 56 may be shaped to correspond to a rear surface of an upper portion of a lower left canine 70 b, each of the lower incisors 68, and a lower right canine 70 a. So disposed, the forward edge 56 may contact or may be immediately adjacent to the rear surface of the upper portion of the lower left canine 70 b, each of the lower incisors 68, and a lower right canine 70 a. Moreover, as illustrated in FIG. 3, a top surface 60 of the forward portion 28 may be disposed adjacent to a top edge of one or more of the of the user's lower anterior teeth 122 (e.g., each of the lower left canine 70 b, each of the lower incisors 68, and the lower right canine 70 a) when viewed along the central axis C that is parallel to or coaxial with the Y-axis such that when the user's upper teeth 40 and lower teeth 42 engage the right lateral engagement portion 16 a and left lateral engagement portion 16 b, a vertical gap G exists between the top surface 60 of the forward portion 28 and a bottom edge of each of the upper central incisors 62 and each of the upper lateral incisors 64. Such a gap G allows the user to drink liquids with the bio-facilitation mouthpiece 10 inserted in the user's mouth. The gap G also allows the user to breathe and talk comfortably while the bio-facilitation mouthpiece 10 is inserted, thereby eliminating the need to frequently remove the bio-facilitation mouthpiece 10 during periods of physical exertion (such as a sporting event).

As illustrated in FIGS. 1, 2, 4, 5, 8, 9 and 10, the base portion also includes a skirt portion 34 that downwardly extends from each of the forward portion 28, the right lateral engagement portion 16 a, and the left lateral engagement portion 16 b. The skirt portion 34 includes the inside surface 36 and the outside surface 38, and the outside surface 38 generally conforms in shape to an inside surface of the lower teeth and an upper portion of the lower gum line of the user. The skirt portion 34 may include a right rear edge 72, a left rear edge 74, and a lower edge 76 that extends between the right rear edge 72 and the left rear edge 74. The right rear edge 72 may downwardly extend from the inside edge 52 a of the bottom portion 24 a of the right lateral engagement portion 16 a at or adjacent to the second end 20 a. The right rear edge 72 may have a shape that follows the natural downward contour of the mouth interior. The left rear edge 74 may downwardly extend from the inside edge 52 b of the bottom portion 24 b of the left lateral engagement portion 16 b at or adjacent to the second end 20 b. The left rear edge may have a shape that follows the natural downward contour of the mouth interior. The lower edge 76 may extend from a terminal end of the left rear edge 74 and a terminal edge of the right rear edge 72, and the lower edge 76 may be contoured to correspond with a bottom portion of the user's lower teeth at or adjacent to the user's gum line. Alternatively, the lower edge 76 may be contoured to correspond with a portion of the user's gums a desired distance below the user's gum line. With the lower edge 76 so disposed, the tongue is free to move in the bottom portion of the user's mouth, facilitating the ability of the user to speak clearly with the biofacilitation mouthpiece 10 inserted. The outside surface 38 may include surface impressions 78 that each corresponds to a portion of an inner surface of a corresponding lower tooth such that the portion of the inner surface of the corresponding lower tooth is received into a corresponding cavity of the surface impressions 78.

As illustrated in FIGS. 1 to 6 and 13, the bio-facilitation mouthpiece 10 includes the right flange member 14 a and the left flange member 14 b, with the right flange 14 a member being coupled to the base member 12 adjacent to the right lateral engagement portion 16 a and the left flange member 14 b being coupled to the base member 12 adjacent to the left lateral engagement portion 16 b. More specifically, the right flange member 14 a may include an upper flange portion 80 a and a lower flange portion 82 a. As illustrated in FIG. 1, the upper flange portion 80 a may upwardly extend in a vertical or substantially vertical direction from the outer edge 50 a of the top portion 22 a of the right lateral engagement portion 16 a. The upper flange portion 80 a may have a rear edge 84 a that upwardly extends from a point at or adjacent to the second end 20 a of the right lateral engagement portion 16 a, and the rear edge 84 a may have a curved or contoured shape that is adapted to correspond to the shape of the user's mouth in the area between the user's upper right posterior teeth 44 a and an upper interior portion of the user's cheek. The rear edge 84 a may be disposed along or adjacent to the middle portion of the user's right upper third molar tooth.

As illustrated in FIGS. 1 and 13, an upper edge 86 a may extend from the terminal end of the rear edge 84 a, and the upper edge 86 a may extend to a point at or adjacent to the first end 18 a of the right lateral engagement portion 16 a. So disposed, the upper edge 86 a may be vertically offset from the outside edge 50 a of the top portion 22 a of the right lateral engagement portion 16 a. The intersection of the upper edge 86 a and the rear edge 84 a may be rounded to avoid sharp corners that may cause discomfort to a user when the bio-facilitation mouthpiece 10 is disposed in a user's mouth. The upper edge 86 a may extend along or adjacent to the gum line of the user's upper right posterior teeth 44 a, and the upper edge 86 a may have a curved, irregular, or contoured shape that is adapted to correspond to the shape of the user's mouth in the area between the user's upper right posterior teeth 44 a and an upper interior portion of the user's cheek. The upper flange portion 80 a may also have a forward edge 88 b that upwardly extends from a point at or adjacent to the first end 18 a of the top portion 22 a of the right lateral engagement portion 16 a to a terminal end of the upper edge 86 a. The forward edge 88 a may be disposed adjacent to the a rearmost portion of the user's right upper canine tooth 66 a or the frontmost portion of the user's right upper first premolar tooth 90 b (as illustrated in FIG. 13). The intersection of the upper edge 86 a and the forward edge 88 a and the intersection of the forward edge 88 a and the first end 18 a of the right lateral engagement portion 16 a may also be rounded to avoid sharp corners that may cause discomfort to a user.

The upper flange portion 80 a may have a uniform thickness or a generally uniform thickness such as 3 mm to 4 mm, for example. So configured, the upper flange portion 80 may have the shape of a contoured, rounded plate, and the upper flange portion may have an inside surface 92 a and an outside surface 94 a. The inside surface 92 a may include surface impressions 96 a that each correspond to a portion of an outer surface of a corresponding upper right posterior tooth 44 a such that the portion of the outer surface of the corresponding upper right posterior tooth is received into a corresponding cavity of the surface impressions 96 a. So configured, the user's mandible is prevented from lateral movement that would disengage the user's upper and/or lower teeth from the bio-facilitation mouthpiece 10.

As illustrated in FIGS. 4 and 13, the right flange member 14 a may also include the lower flange portion 82 a that may downwardly extend in a vertical or substantially vertical direction from the outer edge 54 a of the bottom portion 24 a of the right lateral engagement portion 16 a. The lower flange portion 82 a may have a rear edge 98 a that downwardly extends from a point at or adjacent to the second end 20 a of the right lateral engagement portion 16 a, and the rear edge 98 a may have a curved or contoured shape that is adapted to correspond to the shape of the user's mouth in the area between the user's lower right posterior teeth 46 a and an lower interior portion of the user's cheek. The rear edge 98 a may be disposed along or adjacent to the middle portion of the user's right lower third molar tooth. A bottom edge 100 a may extend from the terminal end of the rear edge 98 a, and the bottom edge 100 a may extend to a point at or adjacent to the first end 18 a of the right lateral engagement portion 16 a. So disposed, the bottom edge 100 a may be vertically offset from the outside edge 54 a of the right lateral engagement portion 16 a. The intersection of the bottom edge 100 a and the rear edge 98 a may be rounded to avoid sharp corners that may cause discomfort to a user when the bio-facilitation mouthpiece 10 is disposed in a user's mouth. The bottom edge 100 a may extend along or adjacent to the gum line of the user's lower right posterior teeth 46 a, and the bottom edge 100 a may have a curved, irregular, or contoured shape that is adapted to correspond to the shape of the user's mouth in the area between the user's lower right posterior teeth 46 a and an lower interior portion of the user's cheek. The lower flange portion 82 b may also have a forward edge 102 a that downwardly extends from a point at or adjacent to the first end 18 a of the right lateral engagement portion 16 a to a terminal end of the bottom edge 100 a. Alternatively, the forward edge 102 a may downwardly extend from a point at or adjacent to the first end 18 a of the right lateral engagement portion 16 a to a terminal end of the bottom edge 100 a. The forward edge 102 a may be disposed adjacent to a rearmost portion of the user's right lower canine tooth 70 a or the frontmost portion of the user's right lower first premolar tooth 104 a. The intersection of the bottom edge 100 a and the forward edge 102 a and the intersection of the forward edge 102 a and the first end 18 a of the right lateral engagement portion 16 a may also be rounded to avoid sharp corners that may cause discomfort to a user.

The lower flange portion 82 a may have a uniform thickness or a generally uniform thickness such as 3 mm to 4 mm, for example. So configured, the lower flange portion 82 a may have the shape of a contoured, rounded plate, and the lower flange portion may have an inside surface 108 a and an outside surface 110 a. The inside surface may include surface impressions 106 a that each correspond to a portion of an outer surface of a corresponding lower right posterior tooth 46 a such that the portion of the outer surface of the corresponding lower right posterior tooth is received into a corresponding cavity of the surface impression 106 a. The inside surface 108 a of the lower flange portion 82 a of the right flange member 14 a may cooperate with the bottom portion of the right lateral engagement portion 24 a and the outside surface 38 of the skirt to form a channel 112 a that extends from the forward edge 102 a of the lower flange portion 82 a to the rear edge 98 a of the lower flange portion 82 a, with the channel 112 a adapted to receive one or more of the user's lower right posterior teeth 46 a (such as, for example, the lower right first premolar, the lower right second premolar, the lower right first molar, the lower right second molar, and the lower right third molar). So configured, the user's mandible is further prevented from lateral movement that would disengage the user's upper and/or lower teeth from the bio-facilitation mouthpiece 10.

As illustrated in FIGS. 1 to 3, 5, and 6, the left flange member 14 b may be a mirror-image (i.e., may be symmetrical or generally symmetrical about a central axis C that is parallel to or collinear with the Y-axis of the reference coordinate system provided in FIG. 1) of the right flange member 14 a described above, but the upper flange portion 80 b of the left flange member 14 b may include an inside surface 92 b having surface impressions 96 b that each correspond to a portion of an outer surface of a corresponding upper left posterior tooth 44 b such that the portion of the outer surface of the corresponding upper left posterior tooth is received into a corresponding cavity of the surface impressions 96 b. In addition, the lower flange portion 82 b of the left flange member 14 b may include an inside surface 108 b having surface impressions 106 b that each correspond to a portion of an outer surface of a corresponding lower left posterior tooth 46 b such that the portion of the outer surface of the corresponding lower left posterior tooth is received into a corresponding cavity of the surface impressions 106 b. So configured, the inside surface 108 b of the lower flange portion 82 b of the left flange member 14 b may cooperate with the bottom portion 24 b of the left lateral engagement portion 16 b and the outside surface 38 of the skirt portion 34 to form a channel 112 b that extends from the forward edge 102 b of the lower flange portion 82 b to the rear edge 98 b of the lower flange portion 82 b, with the channel 112 b adapted to receive one or more of the user's lower left posterior teeth 46 b (such as, for example, the lower left first premolar, the lower left second premolar, the lower left first molar, the lower left second molar, and the lower left third molar).

The bio-facilitation mouthpiece 10 may be fabricated as a single, unitary piece, or may be an assembly or two or more pieces that are fixed by any method known in the art, including using adhesives, ultrasonic welding, or mechanical fastening, for example. The bio-facilitation mouthpiece 10 may be comprised of any suitable material. For example, the bio-facilitation mouthpiece 10 may be made from a soft, flexible silicone material or copolymer material. Alternatively, the bio-facilitation mouthpiece 10 may be made from a heat cured flexible resin. For example, the bio-facilitation mouthpiece 10 made be made from SR Ivocap elastomer or Odontosil silicone.

An upper component 114 (illustrated in FIG. 7) may be used along with the bio-facilitation mouthpiece 10 to provide protection to a user's upper anterior teeth. The upper component 114 may be configured to be received on a user's upper (maxillary) teeth and is formed to substantially conform to the contours of the user's upper teeth. The upper component 114 may include an upper edge 116 that is contoured to replicate a user's gum line. In certain embodiments, the upper edge 116 is configured such that it will not contact the user's gums. The upper edge 116 may include curved apexes 118 that occur toward the middle of each tooth, and curved valleys 120 that occur between teeth. The curved apexes 118 and curved valleys 120 may avoid tearing associated with pointed apexes and valleys. The upper component 114 may span a user's entire upper dental arch, including the rearmost molars. However, in certain embodiments, an upper component 114 may not span a user's full upper dental arch. The upper component 114 may be made of any suitable material. For example, the upper component 114 may be made from a soft, flexible copolymer or silicone, or the upper component may be made from a polypropylene/ethylene copolymer material.

The upper component 114 may be formed as a separate and distinct component from the bio-facilitation mouthpiece 10, and a user may optionally position the upper component 114 over the user's upper teeth prior to inserting the bio-facilitation mouthpiece 10. So positioned, as illustrated in FIGS. 6, 8, and 9, portions of the upper component 114 that correspond to the bottom portions of the user's right and left upper posterior teeth 44 a, 44 b may be received into corresponding surface impressions 26 a, 26 b formed in the top portion 22 a, 22 b of each of the right lateral engagement portion 16 a and the left lateral engagement portion 16 b, and portions of the upper component 114 that correspond to the outside portions of the user's right and left upper posterior teeth 44 a, 44 b may be received into corresponding surface impressions 96 a, 96 b formed on the inside surface 92 a, 92 b of each of the right upper flange portion 80 a and the left upper flange portion 80 b. The upper component 114 may be used when a user is participating in a contact sport to provide extra protection for the upper anterior teeth that are not protected by the bio-facilitation mouthpiece 10.

To fabricate the bio-facilitation mouthpiece 10, manual muscle testing is employed to identify a user's unique maxillomandibular position of minimal nociceptive input. It has been found that an optimal maxillomandibular relationship (i.e., the positioning of the mandible, or lower jaw, relative to the maxilla, or upper jaw) exists that enhances neurological function by channeling the nervous system to eliminate nociceptive input. That is, with the maxilla and mandible in an optimal position, neurological clutter is minimized and, as a result, neurological performance, and thus athletic performance, is enhanced.

Manual muscle testing may be employed to identify when nociceptive input is minimized. Generally speaking, manual muscle testing is used to assess changes in muscle function brought about in the central integrative system of the brain's anterior horn motoneurons. The regulation of muscle function is accomplished at a subconscious level. Function and movement are generated by the premotor and motor cortex of the brain and sent to the reticular activating system, hypothalamus and limbic system. A manual muscle test is conducted by having the user resist a challenge to the target muscle or muscle group while a clinician applies a force. Maximum performance of a muscle in response to manual muscle testing demonstrates low nociceptive input (called “facilitation” or “bio-facilitation”) to the central integrative system of the brain.

Manual muscle testing, therefore, allows a clinician to identify an optimal maxillomandibular relationship that results in enhanced athletic performance. That is, when the maxillomandibular relationship is optimized, the user's head is placed in a balanced physiological position on the spinal column that reduces neck stress, and nociceptive input is minimized. Correspondingly, maximum performance of a muscle in response to manual muscle testing demonstrates low nociceptive input. Accordingly, by varying the maxillomandibular relationship and performing related manual muscle testing, a maxillomandibular position (i.e., the optimal maxillomandibular position) can be identified that corresponds with maximum neurologic performance by the user based on facilitation of the central integrative system.

A commonly known and very basic manual muscle test is the isometric deltoid press, where the user resists as the clinician exerts a downward force on an extended arm. Proper positioning is paramount to ensure that the muscle in question is isolated or positioned as the prime mover, minimizing interference from adjacent muscle groups. The ability of the user to maintain the test position against the pressure exerted in the manual muscle test (e.g., the downward force on the extended arm) is an indicator of maximum performance. Instead of the isometric deltoid press, any strong, healthy muscle may be tested to identify performance facilitation of a muscle.

To identify the user's optimal maxillomandibular position, a practitioner may insert a first bite registration device (also known as a bite shim) between the anterior teeth of the user, and the user may move the upper and lower anterior teeth into contact with (or immediately adjacent to) a top surface and a bottom surface, respectively, of the bite shim. The bite shim may be identical to that disclosed in U.S. patent application Ser. No. 13/014,848, the content of which is incorporated herein by reference. The bite shim may be a plastic, arcuate wafer having a predetermined, uniform thickness (such as, for example, 1.5 mm) and the bite shim may be dimensioned and shaped to correspond to the user's anterior dental arch.

With this first bite shim so disposed, the clinician may initiate the manual muscle test, such as the isometric deltoid press, on the user. Accordingly, the user may stand up straight, place the dorsal portion of the user's tongue against the roof of the mouth, and extend a right arm away from the user's body such that the right arm is substantially horizontal. In this position, the clinician may exert a downward force on the user's extended right arm. While the bite shim is designed to maintain a constant and known vertical separation between the upper and lower jaw, the clinician may vary the user's lateral and protrusive maxillomandibular position (i.e., varying the relative lateral position and the relative longitudinal position, respectively, of the user's upper and lower jaw) while performing the manual muscle test to identify the user's optimal vertical, lateral, and protrusive maxillomandibular position. If the clinician identifies a maximum performance in response to the manual muscle test (e.g., adequately resisting the downward force in the isometric deltoid press), an impression (that will be described in more detail below) will be taken of the user's upper and lower anterior teeth relative to the bite shim to record the user's optimal vertical, lateral, and protrusive maxillomandibular position.

If the clinician notes that maximum performance has not been achieved, a second bite shim may be vertically stacked on the first bite shim. The stacked first and second bite shims may be inserted between the anterior teeth of the user, and the user may and the user may move the upper and lower anterior teeth into contact with (or immediately adjacent to) a top surface and a bottom surface, respectively, of the stacked first and second bite shims. The first and second bite shims may be identical, and surface features may be provided on each of the adjacent surfaces of the first and second bite shims to prevent mutual lateral displacement. With this first and second bite shims so disposed, the clinician may again vary the user's relative lateral and protrusive maxillomandibular position and perform the manual muscle test, such as the isometric deltoid press, on the user. If the clinician identifies a maximum performance in response to the isometric deltoid press, an impression will be taken of the user's upper and lower anterior teeth relative to the stacked first and second bite shims. However, if the clinician notes that maximum performance has not been achieved, a third bite shim may be stacked on the first and second bite shims, and the isometric deltoid press is repeated. Additional bite shims may be added in successive isometric deltoid presses until the clinician identifies a maximum performance.

As explained above, when the clinician identifies a maximum performance in response to the manual muscle test, an impression will be taken of the user's upper and lower anterior teeth relative to the bite shim(s) that corresponds to the user's optimal vertical, lateral, and protrusive maxillomandibular position. To take such an impression, wax or any other suitable material is applied to the upper surface of a top bite shim (i.e., the surface in contact with the upper anterior teeth) and a lower surface of a bottom bite shim (i.e., the surface in contact with the lower anterior teeth) or a lower surface of the top bite shim if only a single bite shim is required. The bite shim(s) may then be positioned in the mouth of the user, and the user may position the upper and lower anterior teeth into contact with (or immediately adjacent to) a top surface and a bottom surface, respectively, of the bite shims(s) in the same position in which the upper and lower anterior teeth were disposed during the maximum performance in the manual muscle test. After a suitable amount of curing time (such as 90 seconds, for example), the bite shim(s) and the hardened wax impressions that are secured to the bite shim(s) may be removed from the user's mouth and may be stored prior to beginning the next fabrication step.

The fabrication of the bio-facilitation mouthpiece 10 may also require the creation of a plaster cast of the user's dental arches. To make such a cast, a dental model using a type-4 dental plaster conforming to ISO standard 6873:1998, such as Hydrocal 105, for example, is poured into an upper impression and a lower impression of the user's teeth. Once the impressions set, they become casts. As illustrated in FIG. 11, the upper cast 130 and lower cast 132 are then secured to an articulator 134 (as illustrated in FIG. 11), and the hardened wax impression and bite shim(s) (not shown) are positioned over the appropriate corresponding teeth. By way of the articulator 134 and the hardened wax impressions, the user's upper and lower casts are positioned to replicate the user's optimal maxillomandibular position that corresponds to the maximum performance in response to the isometric deltoid press. The hardened wax impressions and/or the bite shim(s) are removed, and wax may then be applied to the upper and lower casts 130, 132 to approximate the shape and thickness of the bio-facilitation mouthpiece 10, as illustrated in FIG. 11. The clinician may apply the wax to produce a sacrificial wax mouthpiece 136 that exactly corresponds to the shape and thickness of the final bio-facilitation mouthpiece 10. Alternatively, the clinician may apply the wax to produce a sacrificial wax mouthpiece 136 that has excess material (e.g., covers a greater area then the final bio-facilitation mouthpiece 10) such that he clinician may trim away material on the final bio-facilitation mouthpiece 10 to correspond to the contours of the user's mouth. The wax is allowed to dry, and the hardened sacrificial wax mouthpiece 136 is removed from the upper and lower casts 130, 132.

A mold is then made from the hardened sacrificial wax mouthpiece 136 by embedding the hardened sacrificial wax mouthpiece 136 in plaster. The mold is cut along a central longitudinal plane, and the hardened sacrificial wax mouthpiece is then boiled out of the mold, leaving a cavity 138 a, 138 b in each of the mold halves 140 a, 140 b. The mold halves 140 a, 140 b are then secured together within a brass flask, and liquid material is injected into the cavity formed within the mold halves. To prevent the formation of air bubbles in the material, a pressure may be exerted on the brass flask by a flask clamp, and the pressure may be maintained until the end of the curing time. For example, the pressure may be three bar and the curing time may be 30 minutes to up to 5 hours depending on the mouthpiece material chosen. Curing may occur at room temperature or at an elevated temperature and/or pressure. When the material has cured, the bio-facilitation mouthpiece 10 may be removed from the mold halves. Because the material may be resilient and flexible, undercuts formed on the surface of the teeth will not affect the removal of the bio-facilitation mouthpiece from the mold. Additional finishing procedures, such as, for example, trimming, smoothing, deburring, polishing, and/or lacquering, may then be completed.

Instead of using a mold to fabricate the mouthpiece, the bio-facilitation mouthpiece 10 may be generated suing three-dimensional scanning and printing. Specifically, a prototype mouthpiece (not shown) may be created using wax (or any other suitable material) in a manner identical to the creation of the sacrificial wax mouthpiece described above. The prototype mouthpiece may exactly correspond to the shape and thickness of the final bio-facilitation mouthpiece 10. When the prototype mouthpiece has properly cured, the prototype mouthpiece may be removed from the upper and lower casts 130, 132. The prototype mouthpiece may then be scanned by a three-dimensional scanner to create a computer model of the prototype mouthpiece. The computer model may then be provided to a three-dimensional printer, and a final bio-facilitation mouthpiece 10 may be generated by the three-dimensional printer using a desired material. Additional finishing procedures, such as, for example, trimming, smoothing, deburring, polishing, and/or lacquering, may then be completed. Any suitable method or type of three-dimensional scanning and/or three-dimensional printing or model generation (such as, for example, stereolithography, selective laser sintering, and fused deposition modeling) may be used to fabricate the bio-facilitation mouthpiece 10.

In an additional manufacturing step, the upper component 102 may be vacuum formed over the cast of the user's upper dental arch and trimmed as needed to form the curved apexes and curved valleys described above.

The bio-facilitation mouthpiece 10 described above provides a custom laboratory fabricated non-thermoplastic mouthpiece of either soft, silicone type material or flexible resin whose design allows the user to speak clearly, easily breathe orally, drink liquids with the device in place, while offering concussion protection and tooth protection. Wearing the bio-facilitation mouthpiece 10 facilitates neurological performance of the user by reducing neurological clutter, and the user's head is placed in a balanced physiological position on the spinal column that reduces neck stress. Such a custom laboratory fabricated appliance brings about bio-facilitation of a wide range of human physiologic functions or correction of dysfunctions such as temporomandibular joint pain, headaches, neck pain, daytime airway patency, treatment of certain movement disorders, enhance isotonic head, neck, and body posture, head balance, and enhances neurological performance by reducing nociceptive clutter.

A further embodiment of a bio-facilitation mouthpiece 200 is illustrated in FIGS. 15A to 15N and 16, and the bio-facilitation mouthpiece 200 may be similar in shape and function to the embodiment of the bio-facilitation mouthpiece 10 previously described. That is, as illustrated in FIG. 15A, the bio-facilitation mouthpiece 200 may include a forward portion 202 that is similar or identical in shape and/or function to the forward portion 28 of the bio-facilitation mouthpiece 10 (illustrated in FIG. 1). Referring to FIG. 15C, the bio-facilitation mouthpiece 200 may also include a right outer flange member 204 and a right inner flange member 205 that each extends in a substantially vertical direction (i.e., parallel to the Z-axis of the coordinate system of FIG. 15B), and the right outer flange member 204 may be substantially similar to the right flange member 14 a of the bio-facilitation mouthpiece 10 (illustrated in FIG. 1). Referring to FIG. 15C, the bio-facilitation mouthpiece 200 may further include a left outer flange member 206 and a left inner flange member 207 that each extends in a substantially vertical direction, and the left outer flange member 206 may be substantially similar to the left flange member 14 b of the bio-facilitation mouthpiece 10.

Turning to the detailed structure of the bio-facilitation mouthpiece 200 illustrated in FIG. 15A, the bio-facilitation mouthpiece 200 may include the right lateral engagement portion 208 and the left lateral engagement portion 213. The right lateral engagement portion 208 may include the top portion 210 and the bottom portion 212 (illustrated in FIG. 15C, and the top portion 210 may be planar or substantially planar and may be at least partially comprised of the first material 223 (as illustrated in FIG. 15I). After the first material 223 is at least partially melted or softened in a manner that will be described in more detail below, and after establishing the optimal maxillomandibular relationship as previously described, the top portion 210 may include a plurality of surface impressions 219 (see FIG. 15G) that correspond to the size and shape of a bottom portion of one or more of the user's upper right posterior teeth 44 a. For example, the top portion 210 of the right lateral engagement portion 208 may include a plurality of surface impressions that correspond to a bottom portion of each of the user's upper right third molar, the upper right second molar, the upper right first molar, the upper right second premolar, and the upper right first premolar. The bottom portion 212 of the right lateral engagement portion 208 may be disposed opposite the top portion 210, and the bottom portion 212 may be planar or substantially planar and may be at least partially comprised of the first material 223. After the first material 223 is at least partially melted or softened in a manner that will be described in more detail below, the bottom portion 212 may include a plurality of surface impressions 220 (see FIG. 15H) that correspond to the size and shape of a bottom portion of one or more of the user's lower right posterior teeth 46 a. For example, the bottom portion 212 of the right lateral engagement portion 208 may include a plurality of surface impressions 220 that correspond to a bottom portion of each of the user's lower right third molar, the lower right second molar, the lower right first molar, the lower right second premolar, and the lower right first premolar.

The right lateral engagement portion 208 may have any suitable shape that accommodates the desired number of surface impressions 219, 220. For example, the right lateral engagement portion 208 may be elongated and may have a slightly curved shape when viewed along a vertical axis (i.e., the Z-axis provided in the reference coordinate system of FIG. 15B) such that the right lateral engagement portion 208 generally conforms to the shape collectively formed by the upper and lower right posterior teeth 44 a, 46 a (i.e., the molars and premolars) when viewed along a vertical axis. The right lateral engagement portion 208 may be generally elongated along a longitudinally extending line L (illustrated in FIG. 15A) generally disposed in a plane normal to the vertical axis, and the line L may be slightly curved to correspond to the general shape of an axis of symmetry that longitudinally bisects the upper and/or lower right posterior teeth 44 a, 46 a when viewed along a vertical axis. The elongated right lateral engagement portion 208 may have the first end 209 a and the second end 209 b opposite the first end 209 a, and the first material 223 may extend from the first end 209 a and the second end 209 b. The first end 209 a may be adapted to be disposed at or adjacent to a portion of the surface impression 219 that corresponds to the first or second premolars, and the second end 209 b may be adapted to be disposed at or adjacent to a portion of the surface impression 219 that corresponds to the first or second molars.

The right lateral engagement portion 208 may have any suitable width that allows the surface impressions 219, 220 to be formed on each of the top portion 210 and the bottom portion 212. For example, an area of the top portion 210 that extends longitudinally along an inside edge 225 of the top portion 210 may be free from surface impressions, and/or an area of the top portion 210 that extends longitudinally along an outside edge 226 of the top portion 210 may be free from surface impressions. In addition (or alternatively), an area of the bottom portion 212 that extends longitudinally along an inside edge 227 of the bottom portion 212 may be free from surface impressions, and/or an area of the bottom portion 212 that extends longitudinally along an outside edge 2202 of the bottom portion 212 may be free from surface impressions. Alternatively, the surface impressions on the top portion 210 and/or the bottom portion 212 may extend to the inside edge 225, 227 and/or the outside edge 226, 2202 such that no longitudinal space exists.

FIG. 15I illustrates a cross-section of an embodiment of the right lateral engagement portion 208 that is normal to the line L of FIG. 15A. In such a cross-section, the right lateral engagement portion 208 may have a generally elongated shape extending generally along or parallel to the X-Y plane of the reference coordinate system of FIG. 15A. The planar top portion 210 may define an upper boundary of the elongated cross-sectional shape, and the bottom portion 212 may define a lower boundary of the elongated cross-sectional shape. The top portion 210 and the bottom portion 212 may be separated by any suitable vertical distance D2. The first material 223 comprising the top portion 210 may extend from an outer surface 238 a to an inner surface 239 a, and the vertical distance D3 between the outer surface 238 a and the inner surface 239 a may be any suitable value. An inner edge 242 a may be disposed at the intersection of the outer surface 238 a and an inner side surface 352 a of the top portion 210, and the inner edge 242 a may longitudinally extends along all or a portion of the top portion 210 (e.g., along the entire top portion 210 from the first end 209 a of the right lateral engagement portion 208 to the second end 209 b of the right lateral engagement portion 208). The inner edge 242 a may be rounded or contoured, and a radius of the inner edge 242 a may be approximately 50% to 150% of the vertical thickness D3 of the top portion 210. More specifically, the radius of the inner edge 242 a may be approximately 85% to 120% of the vertical thickness D3 of the top portion 210.

In addition, the first material 223 comprising the bottom portion 212 may extend from an outer surface 240 a to an inner surface right outer flange member 204 a, and the vertical distance D4 between the outer surface 240 a and the inner surface 241 a may be any suitable value. The right lateral engagement portion 208 may also include a center portion 266 a that may be made or comprised from the second material 224, and the center portion 266 a may be planar and extend from the first end 209 a of the right lateral engagement portion 208 to the second end 209 b of the right lateral engagement portion 208.

The outer surface 238 a of the top portion 210 and the outer surface 240 a of the bottom portion 212 of the right lateral engagement portion 208 may be vertically (i.e., along or parallel to the Z-axis provided in the reference coordinate system of FIG. 1) separated by a minimum distance D2 to allow the right lateral engagement portion 208 to absorb an upward impact force on the user's mandible. The minimum distance D2 allows for a minimum suitable vertical distance between the lowermost portion of the surface impressions 219 of the top portion 210 (i.e., the portion vertically closest to the outer surface 240 a of the bottom portion 212) and the uppermost portion of the surface impressions 220 of the bottom portion 212 (i.e., the portion vertically closest to the outer surface 238 a of the top portion 210), and this minimum suitable distance allows for the absorption of such an upward blow by the material between the surface impressions 219 formed on the top portion 210 and the surface impressions 220 formed on the bottom portion 212. So configured, the right lateral engagement portion 208 may prevent a rear portion of the user's mandible from perforating the brain, thereby preventing a concussion. The minimum distance D2 may be at least about 3 mm, and may be between about 3 mm and about 10 mm. Preferably, the minimum distance D2 may be between about 5 mm and 7 mm.

As discussed above and as illustrated in FIGS. 15A, 15J, and 15H, the bio-facilitation mouthpiece 200 may also include the left lateral engagement portion 213. The left lateral engagement portion 213 may be a mirror-image (i.e., may be symmetrical or generally symmetrical about a central axis C2 that is parallel to or collinear with the Y-axis of the reference coordinate system provided in FIG. 15A) of the right lateral engagement portion 208 described above, but the left lateral engagement portion 213 may be adapted to receive a bottom portion of one or more of the user's upper left posterior teeth 44 b and lower left posterior teeth 46 b. Specifically, the left lateral engagement portion 213 has the top portion 215 and the bottom portion 217, and the top portion 215 includes a plurality of surface impressions 221 that correspond to the size and shape of a bottom portion of one or more of the user's upper left posterior teeth 44 b. For example, the top portion 215 of the left lateral engagement portion 213 may include a plurality of surface impressions 221 that correspond to upper left third molar, the upper left second molar, the upper left first molar, the upper left second premolar, and the upper left first premolar. The bottom portion 217 of the left lateral engagement portion 213 may be disposed opposite the top portion 215, and the bottom portion 217 includes a plurality of surface impressions 222 that correspond to the size and shape of a bottom portion of one or more of the user's lower left posterior teeth 46 b. For example, the bottom portion 217 of the left lateral engagement portion 213 may include a plurality of surface impressions 222 that correspond to the lower left third molar, the lower left second molar, the lower left first molar, the lower left second premolar, and the lower left first premolar.

The left lateral engagement portion 213 may have any suitable shape that accommodates the desired number of surface impressions. For example, the left lateral engagement portion may be elongated and may have a slightly curved shape when viewed along a vertical axis such that the left lateral engagement portion 213 generally conforms to the shape collectively formed by the upper and lower left posterior teeth 44 b, 46 b when viewed along a vertical axis. The elongated left lateral engagement portion 213 may include the first end 214 a and the second end 214 b opposite the first end 214 a. The first end 214 a may be disposed at or adjacent to a surface impression that corresponds to the first or second premolars, and the second end may be disposed at or adjacent to a surface impression that corresponds to the first or second molars. The left lateral engagement portion 213 may have any suitable width that allows the surface impressions to be formed on each of the top portion 215 and the bottom portion 217, as explained in the discussion of the right lateral engagement portion 208. The left lateral engagement portion 213 may have a cross-sectional shape that is a mirror image of the cross-section of right lateral engagement portion 208 illustrated in FIGS. 15I and 15J. As explained in the discussion of the right lateral engagement portion 208, the surface impressions 221 formed on the top portion 215 and the surface impressions 222 formed on the bottom portion 217 may be vertically separated by a minimum distance D2 to allow the resilient material comprising the mouthpiece to absorb an upward impact force on the user's mandible. The minimum distance D2 may be at least about 3 mm, and may be between about 3 mm and about 8 mm. Preferably, the minimum distance D2 may be between about 4 mm and 5 mm.

FIG. 15J illustrates a cross-section of an embodiment of the left lateral engagement portion 213 that is a mirror-image of the right lateral engagement portion 208 illustrated in FIG. 15J. That is, the left lateral engagement portion 213 may have a generally elongated shape extending generally along or parallel to the X-Y plane of the reference coordinate system of FIG. 15A. The planar top portion 215 may define an upper boundary of the elongated cross-sectional shape, and the bottom portion 217 may define a lower boundary of the elongated cross-sectional shape. The top portion 215 and the bottom portion 217 may be separated by any suitable vertical distance, such as by the vertical distance D2. The first material 223 comprising the top portion 215 may extend from an outer surface 238 b to an inner surface 239 b, and the vertical distance between the outer surface 238 b and the inner surface 239 b may be any suitable value, such as distance D3.

An inner edge 242 b may be disposed at the intersection of the outer surface 238 b and an inner side surface 352 b of the top portion 215, and the inner edge 242 b may longitudinally extend along all or a portion of the top portion 215 (e.g., along the entire top portion 215 from the first end 214 a of the left lateral engagement portion 213 to the second end 214 b of the left lateral engagement portion 213). The inner edge 242 b may be rounded or contoured, and a radius of the inner edge 242 b may be the same or approximately the same as the radius of the inner edge 242 a of the top portion 210 of the right lateral engagement portion 208. In addition, the first material 223 comprising the bottom portion 212 may extend from an outer surface 240 b to an inner surface 241 b, and the vertical distance D4 between the outer surface 240 b and the inner surface 241 b may be any suitable value. The left lateral engagement portion 213 may also include a center portion 266 b that may be made or comprised from the second material 224, and the center portion 266 b may be planar and extend from the first end 214 a of the left lateral engagement portion 213 to the second end 214 b of the left lateral engagement portion 213. The outer surface 238 b of the top portion 215 and the outer surface 240 b of the bottom portion 217 of the left lateral engagement portion 213 may be vertically separated by a minimum distance, such as the minimum distance D2 of the right lateral engagement portion 208, to allow the left lateral engagement portion 213 to absorb an upward impact force on the user's mandible, as described in the discussion of the right lateral engagement portion 208.

As illustrated in FIGS. 15A to 15C, 15G, and 15H, the bio-facilitation mouthpiece 200 may also include a forward portion 202 that may have the general shape of an arch when viewed parallel to or along a vertical axis (the Z-axis of the reference coordinate system of FIG. 1). As illustrated in FIGS. 15M and 15K, the forward portion 202 may include a first end 230 disposed at or adjacent to the first end 209 a of the right lateral engagement portion 208 and the second end 231 disposed at or adjacent to the first end 214 a of the left lateral engagement portion 213. So disposed, the forward portion 202, the right lateral engagement portion 208, and the left lateral engagement portion 213 may have a U-shape or a rounded V-shape when viewed parallel to or along a vertical axis (as illustrated in FIG. 14A, for example). An upper edge 232 of the forward portion 202 may be generally contoured to correspond to the shape of the interior surface of a user's lower posterior teeth 58. When the bio-facilitation mouthpiece 200 is disposed in a user's mouth, the upper edge 232 may be disposed vertically above a top portion of the user's lower posterior teeth 58. A wall portion 235 may be extend vertically between the upper edge 232 and a lower edge 234. The upper edge 232 may include a projection edge portion 233 that may be outwardly curved and may extend vertically downward towards the lower edge 234 of the forward portion 202. For example, the projection edge portion 233 may be partially-circular and may be contained in a reference plane (or substantially contained in a reference plane) that may be angled (e.g., acutely angled, or, more specifically, downwardly acutely angled) relative to a second reference plane that is parallel to the X-Y axis of the reference coordinate system of FIG. 15A. The projection edge portion 233 may partially define a projection feature 236 that may be further defined by a body edge 237 that may have a rounded U-shape or V-shape. The projection feature 236 may have a curved or rounded shape that tapers from the projection edge portion 233 to the body edge 237.

As illustrated in FIG. 15A and 16, the upper edge 232 (and at least part of the projection edge portion 233) of the forward portion 202 may be disposed vertically above or adjacent to a top edge of one or more of the of the user's lower anterior teeth 122 (e.g., each of the lower left canine 70 b, each of the lower incisors 68, and the lower right canine 70 a) when viewed along the central axis C2 that is parallel to or coaxial with the Y-axis such that when the user's upper teeth 40 and lower teeth 42 engage the right lateral engagement portion 208 and left lateral engagement portion 213, a vertical gap G2 exists between the upper edge 232 of the forward portion 202 and a bottom edge of each of the upper central incisors 62 and each of the upper lateral incisors 64. Such a gap G2 allows the user to drink liquids with the bio-facilitation mouthpiece 200 inserted in the user's mouth. The gap G2 also allows the user to breathe and talk comfortably while the bio-facilitation mouthpiece 200 is inserted, thereby eliminating the need to frequently remove the bio-facilitation mouthpiece 200 during periods of physical exertion (such as a sporting event). The outwardly and downwardly projecting projection feature 236 further simplifies the ability of a user to drink liquids, for example, by providing a shape adapted to receive a straw portion or spout portion of a water bottle.

As illustrated in FIGS. 15A to 15C, the bio-facilitation mouthpiece 200 includes the right outer flange member 204 and the left outer flange member 206, with the right outer flange member 204 member being coupled to a portion of the right lateral engagement portion 208 and the left outer flange member 206 being coupled to a portion of the left lateral engagement portion 213. More specifically, as illustrated in FIG. 15L, the right outer flange member 204 may include an upper flange portion 243 and a lower flange portion 244. The upper flange portion 243 may upwardly extend in a vertical or substantially vertical direction from the outer edge 226 of the top portion 210 of the right lateral engagement portion 208. The upper flange portion 243 may have a rear edge 245 that upwardly extends from a point at or adjacent to the second end 209 b of the right lateral engagement portion 208, and the rear edge 245 may have a curved or contoured shape that is adapted to correspond to the shape of the user's mouth in the area between the user's upper right posterior teeth 44 a and an upper interior portion of the user's cheek. The rear edge 245 may be disposed along or adjacent to the middle portion of the user's right upper third molar tooth.

As illustrated in FIG. 15L, an upper edge 246 may extend from the terminal end of the rear edge 245, and the upper edge 246 may extend to a point at or adjacent to the first end 209 a of the right lateral engagement portion 208. So disposed, the upper edge 246 may be vertically offset or substantially vertically offset from the outside edge 226 of the top portion 210 of the right lateral engagement portion 208. The intersection of the upper edge 246 and the rear edge 245 may be rounded to avoid sharp corners that may cause discomfort to a user when the bio-facilitation mouthpiece 200 is disposed in a user's mouth. As illustrated in FIG. 15D, the upper edge 246 may be disposed a vertical distance 392 from a reference centerline 390 that bisects or substantially bisects the right lateral engagement portion 208 (or the left lateral engagement portion 213). More specifically, the upper edge 246 may extend along or adjacent to the gum line of the user's upper right posterior teeth 44 a, and the upper edge 246 may have a linear shape that is adapted to generally correspond to the shape of the user's mouth in the area between the user's upper right posterior teeth 44 a and an upper interior portion of the user's cheek. The upper flange portion 243 may also have a forward edge 247 that upwardly extends from a point at or adjacent to the first end 209 a of the top portion 210 of the right lateral engagement portion 208 to a terminal end of the upper edge 246. The forward edge 247 may be disposed adjacent to the a rearmost portion of the user's right upper canine tooth 66 a or the frontmost portion of the user's right upper first premolar tooth 90 b (as illustrated in FIG. 13). The intersection of the upper edge 246 and the forward edge 247 and the intersection of the forward edge 247 and the first end 209 a of the right lateral engagement portion 208 may also be rounded to avoid sharp corners that may cause discomfort to a user.

Referring to FIG. 15I, the upper flange portion 243 may have a uniform thickness or a generally uniform thickness such as 3 mm to 4 mm, for example. So configured, the upper flange portion 243 may have the shape of a contoured, rounded plate, and the upper flange portion 243 may have a first inside surface 248 and a first outside surface 249. The portion of the upper flange portion 243 between the first inside surface 248 and the first outside surface 249 may comprise or be formed from the second material 224. As illustrated in FIG. 15I, the center portion 266 a of the right lateral engagement portion 208 may be unitarily formed with all or a portion of the upper flange portion 243, such as the portion between the first inside surface 248 and the first outside surface 249.

Referring to FIG. 15I, the upper flange portion 243 may also include an inside portion 262 that may be coupled to or formed on all or a portion of the first inside surface 248, and the inside portion 262 may be comprised of the first material 223. For example, the inside portion 262 may longitudinally extend from the rear edge 245 to the forward edge 247 of the upper flange portion 243, and the inside portion 262 may vertically extend from the upper edge 246 to the outer surface 238 a of the top portion 210 of the right lateral engagement portion 208. The inside portion 262 may also include a second inside surface 263 and a second outside surface 264, and the second inside surface 263 may be adjacent to or in contact with the first outside surface 249. The outside edge 226 may be an intersecting edge of the top portion 210 and the inside portion 262. In cross-section, the top portion 210 and the inside portion 262 may have an L-shape or an approximate L-shape.

As illustrated in FIGS. 15I and 15L, the right outer flange member 204 may include the lower flange portion 244. As illustrated in FIG. 15I, the lower flange portion 244 may downwardly extend in a vertical or substantially vertical direction from the outside edge 228 of the bottom portion 212 of the right lateral engagement portion 208. Referring to FIG. 15L, the lower flange portion 244 may have a rear edge 268 that downwardly extends from a point at or adjacent to the second end 209 b of the right lateral engagement portion 208, and the rear edge 268 may have a curved or contoured shape that is adapted to correspond to follow the natural downward contour of the mouth interior. That is, the rear edge 268 may be disposed along or adjacent to the middle portion of the user's right lower third molar tooth.

As illustrated in FIG. 15L, a lower edge 269 may extend from the terminal end of the rear edge 268, and the lower edge 269 may extend to a point at or adjacent to the first end 209 a of the right lateral engagement portion 208. So disposed, the lower edge 269 may be vertically offset or substantially vertically offset from the outside edge 228 of the bottom portion 212 of the right lateral engagement portion 208. As illustrated in FIG. 15D, the lower edge 269 may be disposed a vertical distance 391 from a reference centerline 390 that bisects or substantially bisects the right lateral engagement portion 208 (or the left lateral engagement portion 213). The vertical distance 391 may have any suitable value, and may be equal to or substantially equal to the vertical distance 392. More specifically, the lower edge 269 may be adapted to be aligned with a bottom portion of the user's lower teeth at or adjacent to the user's gum line. Alternatively, the lower edge 269 may be contoured to correspond with a portion of the user's gums a desired distance below the user's gum line. The intersection of the lower edge 269 and the rear edge 268 may be rounded to avoid sharp corners that may cause discomfort to a user when the bio-facilitation mouthpiece 200 is disposed in a user's mouth. With the lower edge 269 so disposed, the tongue is free to move in the bottom portion of the user's mouth, facilitating the ability of the user to speak clearly with the biofacilitation mouthpiece 200 inserted. The lower flange portion 244 may also have a forward edge 270 that downwardly extends from a point at or adjacent to the first end 209 a of the right lateral engagement portion 208 to a terminal end of the lower edge 269. The intersection of the lower edge 269 and the forward edge 270 and the intersection of the forward edge 270 and the first end 209 a of the right lateral engagement portion 208 may also be rounded to avoid sharp corners that may cause discomfort to a user.

Referring to FIG. 15I, the lower flange portion 244 may have a uniform thickness or a generally uniform thickness such as 3 mm to 4 mm, for example. So configured, the lower flange portion 244 may have the shape of a contoured, rounded plate, and the lower flange portion 244 may be generally vertically aligned with the upper flange portion 243 such that the right outer flange member 204 may have the shape of a contoured, rounded plate. The lower flange portion 244 may have a first inside surface 271 and a first outside surface 272. The portion of the lower flange portion 244 between the first inside surface 271 and the first outside surface 272 may comprise or be formed from the second material 224. As illustrated in FIG. 15I, the center portion 266 a of the right lateral engagement portion 208 may be unitarily formed with all or a portion of the lower flange portion 244, such as the portion between the first inside surface 271 and the first outside surface 272.

Still referring to FIG. 15I, the lower flange portion 244 may also include an first inside portion 273 that may be coupled to or formed on all or a portion of the first inside surface 271, and the first inside portion 273 may be comprised of the first material 223. For example, the first inside portion 273 may longitudinally extend from the rear edge 268 to the forward edge 270 of the lower flange portion 244, and the first inside portion 273 may vertically extend from the lower edge 269 to the outer surface 240 a of the bottom portion 212 of the right lateral engagement portion 208. The first inside portion 273 may also include a second inside surface 274 and a second outside surface 275, and the second inside surface 274 may be adjacent to or in contact with the first outside surface 272. The outside edge 228 may be an intersecting edge of the bottom portion 212 and the first inside portion 273. The second outside surface 275 may be adapted to include surface impressions 276 (see FIG. 15H) that each corresponds to a portion of an inner surface of a corresponding lower tooth such that the portion of the inner surface of the corresponding lower tooth is received into a corresponding cavity of the surface impressions 276.

As illustrated in FIGS. 15C, 15I, 15K, and 15N, the bio-facilitation mouthpiece 200 also includes the right inner flange member 205, and, as illustrated in FIG. 15I, the right inner flange member 205 may downwardly extend in a vertical or substantially vertical direction from an inner lateral portion of the right lateral engagement portion 208, such as an inner edge 282 of the right lateral engagement portion 208. As shown in FIG. 15N, the right inner flange member 205 may have a rear edge 284 that downwardly extends from a point at or adjacent to the second end 209 b of the right lateral engagement portion 208, and the rear edge 284 may have a curved or contoured shape that is adapted to correspond to follow the natural downward contour of the mouth interior. That is, the rear edge 284 may be disposed along or adjacent to the middle portion of the user's right lower third molar tooth. As illustrated in FIG. 15N, a lower edge 286 may extend from the terminal end of the rear edge 284, and the lower edge 286 may extend to a point at or adjacent to the first end 209 a of the right lateral engagement portion 208. So disposed, the lower edge 286 may be vertically offset or substantially vertically offset from the inside edge 227 of the bottom portion 212 of the right lateral engagement portion 208 (or from the outside edge 228 of the bottom portion 212 of the right lateral engagement portion 208). The lower edge 286 may be adapted to be aligned with a bottom portion of the user's lower teeth at or adjacent to the user's inner gum line. Alternatively, the lower edge 286 may be contoured to correspond with a portion of the user's gums a desired distance below the user's gum line. The intersection of the lower edge 286 and the rear edge 284 may be rounded to avoid sharp corners that may cause discomfort to a user when the bio-facilitation mouthpiece 200 is disposed in a user's mouth. The right inner flange member 205 may also have a forward edge 288 that downwardly extends from a point at or adjacent to the first end 209 a of the right lateral engagement portion 208 to a terminal end of the lower edge 286. The forward edge 288 may be disposed at any suitable location, and the forward edge 288 may be adapted to be substantially aligned with the forward edge of the 270 of the lower flange portion 244. The intersection of the lower edge 286 and the forward edge 288 and the intersection of the forward edge 288 and the first end 209 a of the right lateral engagement portion 208 may also be rounded to avoid sharp corners that may cause discomfort to a user.

Referring to FIG. 15I, the right inner flange member 205 may have a uniform thickness or a generally uniform thickness such as 3 mm to 4 mm, for example. So configured, the right inner flange member 205 may have the shape of a contoured, rounded plate. The right inner flange member 205 may have a first inside surface 290 and a first outside surface 292. The portion of the right inner flange member 205 between the first inside surface 290 and the first outside surface 292 may comprise or be formed from the second material 224. As illustrated in FIG. 15I, the center portion 266 a of the right lateral engagement portion 208 may be unitarily formed with all or a portion of the right inner flange member 205, such as the portion between the first inside surface 290 and the first outside surface 292. So configured, the center portion 266 a of the right lateral engagement portion 208, the right inner flange member 205 between the first inside surface 290 and the first outside surface 292, the upper flange portion 243 between the first inside surface 248 and the first outside surface 249, and the lower flange portion 244 between the first inside surface 271 and the first outside surface 272 may be all be unitarily formed and comprise or be formed from the second material 224. As illustrated in FIG. 15I, the right lateral engagement portion 208, the right inner flange member 205, the upper flange portion 243, and the lower flange portion 244 may have the cross-sectional shape of a lower-case “h”. More specifically, the center portion 266 a of the right lateral engagement portion 208, the right inner flange member 205 between the first inside surface 290 and the first outside surface 292, the upper flange portion 243 between the first inside surface 248 and the first outside surface 249, and the lower flange portion 244 between the first inside surface 271 and the first outside surface 272 may have the shape of a lower-case “h”.

Still referring to FIG. 15I, the right inner flange member 205 may also include an second inside portion 294 that may be coupled to or formed on all or a portion of the first inside surface 290, and the second inside portion 294 may be comprised of the first material 223. For example, the second inside portion 294 may longitudinally extend from the rear edge 284 to the forward edge 288 of the right inner flange member 205, and the second inside portion 294 may vertically extend from the lower edge 286 to the outer surface 240 a of the bottom portion 212 of the right lateral engagement portion 208. The second inside portion 294 may also include a second inside surface 296 and a second outside surface 298, and the second inside surface 296 may be adjacent to or in contact with the first inside surface 290. The inside edge 227 may be an intersecting edge of the bottom portion 212 and the second inside portion 294. The second outside surface 298 may be adapted to include surface impressions 300 (see FIG. 15H) that each corresponds to a portion of an inner surface of a corresponding lower tooth such that the portion of the inner surface of the corresponding lower tooth is received into a corresponding cavity of the surface impressions 300. In the cross-sectional view of FIG. 15I, the bottom portion 212, the first inside portion 273, and the second inside portion 294 may have an inverted U-shape or an approximate inverted U-shape such that the bottom portion 212, the first inside portion 273, and the second inside portion 294 cooperate to form an elongated channel 302 from the first end 209 a to the second end 209 b of the right lateral engagement portion 208.

As illustrated in FIGS. 15A to 15C, 15J, 15G, 15H, 15J, 15K, and 15L, the bio-facilitation mouthpiece 200 also includes the left outer flange member 206 that is coupled to a portion of the left lateral engagement portion 213. More specifically, left outer flange member 206 may be a mirror-image of, but otherwise identical to, the right outer flange member 204 (i.e., a mirror image about that central axis C2 of FIG. 15A) and, as illustrated in FIGS. 15K and 15J, may include an upper flange portion 278 (that is a mirror image of, but otherwise identical to, the upper flange portion 243 of the right outer flange member 204) and a lower flange portion 280 (that is a mirror image of, but otherwise identical to, the lower flange portion 244 of the right outer flange member 204). As illustrated in FIG. 15J, the upper flange portion 278 may upwardly extend in a vertical or substantially vertical direction from the top portion 215 of the left lateral engagement portion 213. Referring now to FIG. 15K. the upper flange portion 278 may have a rear edge 304, an upper edge 306, and a forward edge 308 that each corresponds in shape and position to the rear edge 245, upper edge 246, and forward edge 247 of the upper flange portion 243 of the right outer flange member 204. Referring to FIG. 15J, the upper flange portion 278 may also include an inside portion 310 that may be comprised of the first material 223. In cross-section, the top portion 215 and the inside portion 310 may have an L-shape or an approximate L-shape.

As illustrated in FIGS. 15J and 15K, the left outer flange member 206 may also include the lower flange portion 280 that may be a mirror image of, but otherwise identical to, the lower flange portion 244 that may downwardly extend in a vertical or substantially vertical direction from the bottom portion 217 of the left lateral engagement portion 213. As illustrated in FIG. 15K. the lower flange portion 280 may have a rear edge 312, a lower edge 314, and a forward edge 316 that each corresponds in shape and position to the rear edge 268, lower edge 269, and forward edge 270 of the lower flange portion 244 of the right outer flange member 204. Referring to FIG. 15J, the lower flange portion 280 may also include a first inside portion 320 that may be comprised of the first material 223.

As illustrated in FIGS. 15J and 15K, the bio-facilitation mouthpiece 200 also includes the left inner flange member 207 that may be coupled to an inner lateral portion of the left lateral engagement portion 213. More specifically, the left inner flange member 207 may be a mirror-image of, but otherwise identical to, the right inner flange member 205 (i.e., a mirror image about that central axis C2 of FIG. 15A). As illustrated in FIGS. 15J and 15K, the left inner flange member 207 may have a rear edge 322, a lower edge 324, and a forward edge 326 that each corresponds in shape and position to the rear edge 284, lower edge 286, and forward edge 288, respectively, of the lower flange portion 244 of the right inner flange member 205. Referring to FIG. 15J, the left inner flange member 207 may also include a second inside portion 328 that may be comprised of the first material 223. In the cross-sectional view of FIG. 15J, the bottom portion 217, the first inside portion 273, and the second inside portion 294 may have an inverted U-shape or an approximate inverted U-shape such that the bottom portion 212, the first inside portion 320, and the second inside portion 328 cooperate to form an elongated channel 330 from the first end 214 a to the second end 214 b of the left lateral engagement portion 213.

Any or all portions of the bio-facilitation mouthpiece 200 that are to be formed to contour to the shape of a user's teeth may be made from or comprise (or partially made from or partially comprise) the first material 223, and any or all portions of the bio-facilitation mouthpiece 200 that are not to be formed to contour to the shape of a user's teeth may be made from or comprise (or partially made from or partially comprise) the second material 224 that is different than the first material 223. For example, at least a portion of the right lateral engagement portion 208 and the left lateral engagement portion 213 (e.g., all or a portion of one or both the top portions 210, 215 and the bottom portions 212, 217) may comprise or be made from the first material. In addition, at least a portion of at least one of the right outer flange member 204, the right inner flange member 205, the left outer flange member 206, the left inner flange member 207, and/or the forward portion 202 may comprise or be made from the second material 224. In some embodiments, at least all or a part of an inner surface of the right outer flange member 204 (or the entire right outer flange member 204), an inner surface of the right inner flange member 205 (or the entire right inner flange member 205), an inner surface of the left outer flange member 206 (or the entire left outer flange member 206), and/or an inner surface of the left inner flange member 207 (or the entire left inner flange member 207) may comprise or be made from the first material 223. The first material 223 may be coupled to the second material 224 in any suitable manner. For example, the first material 223 may be co-molded (i.e., formed during the fabrication process) to or with the second material 224. In other embodiments, an adhesive may be used to couple the first material 223 to the second material 224. In further embodiments, an undercut or tab portion of the second material 224 may embed in and retain the first material 223.

The first material 223 may have one or more physical properties that are different than the second material. For example, the first material 223 may have a melting point or softening point that is lower than the second material. The first material 223 may be a thermoplastic, for example, a Thermoplastic Elastomeric (TPE) such as a polystyrene and rubber-modified polystyrene (e.g., Dioshy TPE GP-0210M) having a melt index of 22.83 g/10 min. The second material 224 may be a thermoplastic, for example a Thermoplastic Elastomeric (TPE) such as a polystyrene and rubber-modified polystyrene (e.g. Dioshy TPE 980E-NC) having a melt index of 9.72 g/10 min. The first material 223 may soften or become less rigid when immersed for a period of time (e.g., between 10 seconds and 60 seconds) in water (or any suitable fluid) that is between about 150° F. and about 200° F. More specifically, the first material 223 may soften when immersed for about 30 to 60 seconds in water that is between about 170° F. and about 190° F. The second material 224 may have a rigidity that may not change or significantly change when immersed for a period of time (e.g., between 10 seconds and 60 seconds) in water that is between about 150° F. and about 200° F., for example for about 30 seconds in water that is between about 170° F. and about 180° F.

As illustrated in FIGS. 14A to 14C, a bite position assembly 250 (also called a “bite guide template”) may be used with the bio-facilitation mouthpiece 200. The bite position assembly 250 may include a plurality of individual bite members 252 (also called “Bite Guides”) that each act as an assembly of differently sized shims as previously described. That is, a first bite member 252 a may have a head portion 260 and a body portion 256 that may be removably secured to a hub 258. Two or more bite members 252 (for example, nine bite members 252 a to 252 i) may be radially arrayed around the hub 258. A lower portion 332 of each body portion 256 may be adapted to be broken or sheared off of the hub 258 (by scoring, by reduced material thickness, etc, for example) such that each of the bite members 252 is removable from the hub 258. The hub 258 may have any suitable shape to allow two or more bite members 252 to be removably secured thereto. For example, the hub 258 may be elongated and each body portion 256 may be disposed in a parallel configuration.

As illustrated in FIG. 14D, the head portion 256 of each bite member 252 may have a center portion 334 that is surrounded by an inner ridge 336 and an outer ridge 338 that each extend radially (i.e., normal to a longitudinal axis L of the body portion 256 of FIG. 4D) or substantially radially along opposite lateral edges of the center portion 334. The inner ridge 336 and the outer ridge may be curved (e.g., may form a partially-circular arc) and may be offset in the longitudinal direction (a direction parallel to a longitudinal axis L of the body portion 256). As illustrated in FIG. 14E, the center portion 334 may be planar or substantially planar and may have a top surface 340 and a bottom surface 342, and the inner ridge 336 may be formed on both sides of the center portion 334. That is, the inner ridge 336 may include a top inner ridge 344 that extends upwardly from the top surface 340 of the center portion 334 and a bottom inner ridge 346 that extends downwardly from the bottom surface 342 of the center portion 334. The outer ridge 338 may be formed on both sides of the center portion 334, and the outer ridge 338 may include a top outer ridge 348 that extends upwardly from the top surface 340 of the center portion 334 and a bottom outer ridge 350 that extends downwardly from the bottom surface 342 of the center portion 334. As illustrated in FIG. 14F, the top outer ridge 348 and the bottom outer ridge 350 may be longitudinally offset and the top inner ridge 344 and the bottom inner ridge 346 may be longitudinally offset. The longitudinal offset may vary depending on the bite member 252. In some embodiments, such as that of FIG. 14E, the top outer ridge 348 and the bottom outer ridge 350 may be longitudinally aligned and the top inner ridge 344 and the bottom inner ridge 346 may be longitudinally aligned.

As illustrated in FIG. 14E, an inner wall 352 of the top inner ridge 144 may be longitudinally offset from an inner wall 354 of the top outer ridge 348 by an offset distance OD1, and an inner wall 356 of the bottom inner ridge 346 may be longitudinally offset from an inner wall 358 of the bottom outer ridge 350 by an offset distance OD2. The offset distances OD1, OD2 may be known and may vary for each bite member 252. In some embodiments, the offset distance OD1 may be the same as the offset distance OD2. However, the offset distance OD1 may be greater than or less than the offset distance OD2. The offset distances OD1, OD2 may be within the range of 0.100″ to 0.400″, for example. The longitudinal offset (i.e., the offset distances OD1, OD2) results in a protrusive and/or lateral mandibular position for the user. Moreover, as illustrated in FIG. 14E, the center portion 334 may have a known thickness T (i.e., a measurement normal to the longitudinal axis of the body portion 256, or the vertical distance between the top surface 340 and the bottom surface 342, for example) and the thickness T may vary for each bite member 252. The thickness T of a first bite member 252 a may vary from the thickness T of a second bite member 252 b by any suitable value, such as 0.5 mm, 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm, 9.0 mm, 9.5 mm, 10 mm, 10.5 mm, 11.0 mm, 11.5 mm, and 12.0 mm, for example. The thickness T results in a vertical mandibular position for the user.

The bite position assembly 250, and each bite member 252, may be made from any suitable material, such as a rigid plastic that will not deform or substantially deform when a user applies biting pressure on the center portion. The bite position assembly 250 may be packaged or provided with the bio-facilitation mouthpiece 200 such that the bite position assembly 250 and bio-facilitation mouthpiece 200 are both component of parts of a mouthpiece device and positioning assembly.

So configured, each bite member 252 may be placed between the anterior teeth of the user, and the user may move the upper and lower anterior teeth into contact with (or immediately adjacent to) the top surface 340 and the bottom surface 342, respectively, of the center portion 334 between the inner ridge 336 and the outer ridge 338 (e.g., between the inner wall 352 of the top inner ridge 144 and the inner wall 354 of the top outer ridge 348 and between the inner wall 356 of the bottom inner ridge 346 and the inner wall 358 of the bottom outer ridge 350). Consequently, the inner ridge 336 and the outer ridge 338 maintain the top and bottom anterior teeth in a predetermined longitudinally-offset portion (or on a position with no longitudinal offset), and the thickness T of the center portion separates the upper and lower anterior teeth by a known and predetermined distance. Thus, by using different bite members 252 each with a different offset distance OD and/or thickness T, a user's optimal vertical, lateral, and protrusive maxillomandibular position may be identified in the manner previously described. That is, a practitioner may insert the head portion 260 of a first bite member 252 a between the anterior teeth of the user, and the user may move the upper and lower anterior teeth into contact with (or immediately adjacent to) the top surface 340 and the bottom 342 surface, respectively, of the center portion 334 between the inner ridge 336 and the outer ridge 338. The clinician may then initiate the manual muscle test, such as the isometric deltoid press, on the user, for example. If manual muscle testing indicates that the first bite member 252 a does not result in the optimal vertical, lateral, and protrusive maxillomandibular position, a second bite member 252 b, third bite member 252 c, fourth bite member 252 d, etc. may be used until the a user's optimal vertical, lateral, and protrusive maxillomandibular position is identified. Instead of the bite members 252, the previously-described shims could also be used identify the optimal vertical, lateral, and protrusive maxillomandibular position in the manner previously described.

When the clinician identifies a maximum performance in response to the manual muscle test (e.g., adequately resisting the downward force in the isometric deltoid press), the first material 223 of the bio-facilitation mouthpiece 200 may softened or partially melted (e.g., the bio-facilitation mouthpiece 200 may be immersed for about 30 seconds in water that is between about 170° F. and about 180° F.) without softening or reducing the rigidity of the second material 234. After the first material 233 is softened or partially melted, the bio-facilitation mouthpiece 200 may be placed in the user's mouth without the user clenching his or her teeth. The bite member 252 that resulted in the optimal vertical, lateral, and protrusive maxillomandibular position is then inserted between the anterior teeth of the user (through the front gap G2 visable in FIG. 16), and the user bites down on both the bite member 252 and the bio-facilitation mouthpiece 200. An impression of the user's teeth that contact the softened first material 223 is thus taken, and after a sutiable amount of time (e.g., 30 seconds to 5 minutes), the bio-facilitation mouthpiece 200 is removed from the mouth of the user. The bio-facilitation mouthpiece 200 may then be placed into a container of cold water to complete the cooling process. Once cooled, the bio-facilitation mouthpiece 200 will maintain the impression of the user's teeth in the first material such that when the user wears the bio-facilitation mouthpiece 200, the user's optimal vertical, lateral, and protrusive maxillomandibular position will be maintained. One skilled in the art would recognize that the bio-facilitation mouthpiece 200 provides a custom-fit and relatively inexpensive athletic performance mouthpiece that facilitates neurological performance of the user by reducing neurological clutter, as previously described.

While various embodiments have been described above, this disclosure is not intended to be limited thereto. Variations can be made to the disclosed embodiments that are still within the scope of the appended claims. 

What is claimed is:
 1. A bio-facilitation mouthpiece adapted to facilitate optimal neurological function, the bio-facilitation mouthpiece comprising: an elongated right lateral engagement portion having a first end and a second end opposite the first end, the right lateral engagement portion having a top portion and a bottom portion, the top portion adapted to include a plurality of surface impressions that correspond to the size and shape of a bottom portion of one or more of the user's upper right posterior teeth and the bottom portion adapted to include a plurality of surface impressions that correspond to the size and shape of a top portion of one or more of the user's lower right posterior teeth; an elongated left lateral engagement portion having a first end and a second end opposite the first end, the left lateral engagement portion having a top portion and a bottom portion, the top portion adapted to include a plurality of surface impressions that correspond to the size and shape of a bottom portion of one or more of the user's upper left posterior teeth and the bottom portion adapted to include a plurality of surface impressions that correspond to the size and shape of a top portion of one or more of the user's lower left posterior teeth; a forward portion having a first end disposed adjacent to the first end of the right lateral engagement portion and a second end disposed adjacent to the first end of the left lateral engagement portion, wherein the forward portion includes an upper edge disposed adjacent to a top edge of one or more of the user's lower anterior teeth such that a vertical gap exists between the upper edge and a bottom edge of each of the user's upper central incisors, with the vertical gap adapted to facilitate breathing and talking; a right outer flange member coupled to the right lateral engagement portion; and a left outer flange member coupled to the left lateral engagement portion, wherein at least a portion of the top portion and bottom portion of each the right lateral engagement portion and left lateral engagement portion comprises a first material, and wherein at least a portion of each of the forward portion, the right outer flange member, and the left outer flange member comprise a second material, and wherein the first material has one or more physical properties that are different than one or more corresponding physical properties of the second material.
 2. The bio-facilitation mouthpiece of claim 1, wherein the one or more physical properties includes a melting temperature.
 3. The bio-facilitation mouthpiece of claim 1, wherein the first material has a melting temperature at or below a boiling temperature of water, and wherein the second material has a melting temperature above the boiling temperature of water.
 4. The bio-facilitation mouthpiece of claim 3, wherein the first material has a melting temperature between about 150° F. and about 200° F. and wherein the second material has a melting temperature above about 200° F.
 5. The bio-facilitation mouthpiece of claim 1, wherein the forward portion is arch-shaped such that the forward portion, the right lateral engagement portion, and the left lateral engagement portion has a U-shape when viewed along a vertical axis.
 6. The bio-facilitation mouthpiece of claim 1, wherein the top portion of each of the right lateral engagement portion and the left lateral engagement portion are vertically spaced from the bottom portion of the right lateral engagement portion and the left lateral engagement portion by a distance of at least 4 mm to absorb an upward impact force on the user's mandible in a manner that prevents concussions.
 7. The bio-facilitation mouthpiece of claim 1, wherein the right outer flange member includes an upper flange portion and a lower flange portion, and the left flange outer member includes an upper flange portion and a lower flange portion.
 8. The bio-facilitation mouthpiece of claim 7, wherein the upper flange portion of the right outer flange member upwardly extends in a vertical direction from an outer edge of the right lateral engagement portion and the upper flange portion of the left outer flange member upwardly extends in a vertical direction from an outer edge of the left lateral engagement portion.
 9. The bio-facilitation mouthpiece of claim 8, wherein the upper flange portion of the right outer flange member has an upper edge extending along the gum line of the user's upper right posterior teeth and the upper flange portion of the left outer flange member has an upper edge extending along the gum line of the user's upper left posterior teeth.
 10. The bio-facilitation mouthpiece of claim 7, wherein the right outer flange member and the left outer flange member each has the shape of a contoured, rounded plate.
 11. The bio-facilitation mouthpiece of claim 8, wherein the lower flange portion of the right outer flange member downwardly extends in a vertical direction from an outer edge of the right lateral engagement portion and the lower flange portion of the left outer flange member downwardly extends in a vertical direction from an outer edge of the left lateral engagement portion.
 12. The bio-facilitation mouthpiece of claim 11, wherein the lower flange portion of each of the right flange outer member and the left outer flange member has a bottom edge that extends along the gum line of the user's lower posterior teeth.
 13. A mouthpiece device and positioning assembly adapted to facilitate optimal neurological function, the mouthpiece device and positioning assembly comprising: a bio-facilitation mouthpiece comprising: an elongated right lateral engagement portion having a first end and a second end opposite the first end, the right lateral engagement portion having a top portion and a bottom portion, the top portion adapted to include a plurality of surface impressions that correspond to the size and shape of a bottom portion of one or more of the user's upper right posterior teeth and the bottom portion adapted to include a plurality of surface impressions that correspond to the size and shape of a top portion of one or more of the user's lower right posterior teeth; an elongated left lateral engagement portion having a first end and a second end opposite the first end, the left lateral engagement portion having a top portion and a bottom portion, the top portion adapted to include a plurality of surface impressions that correspond to the size and shape of a bottom portion of one or more of the user's upper left posterior teeth and the bottom portion adapted to include a plurality of surface impressions that correspond to the size and shape of a top portion of one or more of the user's lower left posterior teeth; a forward portion having a first end disposed adjacent to the first end of the right lateral engagement portion and a second end disposed adjacent to the first end of the left lateral engagement portion, wherein at least a portion of the top portion and bottom portion of each the right lateral engagement portion and left lateral engagement portion comprises a first material, and wherein at least a portion of the forward portion comprises a second material, and wherein the first material has one or more physical properties that are different than one or more corresponding physical properties of the second material; and two or more bite members, the two or more bite members comprising: a first bite member having a head portion and an elongated body portion, the head portion including a center portion that has a first thickness; a second bite member having a head portion and an elongated body portion, the head portion including a center portion that has a second thickness different than the first thickness, wherein the two or more bite members are adapted to cooperate to determine an optimal vertical and/or lateral maxillomandibular position, and wherein the bio-facilitation mouthpiece is adapted to maintain the user's optimal vertical and/or lateral maxillomandibular position such that optimal neurological function is facilitated.
 14. The mouthpiece device and positioning assembly of claim 13, wherein the center portion of head portion of the first bite member is surrounded by an inner ridge and an outer ridge that each extend radially along opposite lateral edges of the center portion, the inner ridge and the outer ridge being longitudinally separated by a first offset distance, wherein the center portion of head portion of the second bite member is surrounded by an inner ridge and an outer ridge that each extend radially along opposite lateral edges of the center portion, the inner ridge and the outer ridge being longitudinally separated by a second offset distance that is different than the first offset distance, and wherein the inner ridge and the outer ridge of each of the first and second bite members are adapted to cooperate to determine an optimal protrusive and/or lateral maxillomandibular position, and wherein the bio-facilitation mouthpiece is adapted to maintain the user's optimal protrusive and/or lateral maxillomandibular position.
 15. The mouthpiece device and positioning assembly of claim 13, wherein the bio-facilitation mouthpiece includes a right outer flange member coupled to the right lateral engagement portion and a left outer flange member coupled to the left lateral engagement portion, and wherein at least a portion of each of the right outer flange member and the left outer flange member comprise the second material.
 16. A method of fabricating a bio-facilitation mouthpiece for a user, the method comprising: identifying a user's maxillomandibular position of minimal nociceptive input; creating an impression of a portion of the user's upper and lower anterior teeth in the maxillomandibular position of minimal nociceptive input in a first material of a bio-facilitation mouthpiece that is comprised of both the first material and a second material, wherein the first material has a lower melting temperature than the second material, and wherein the user's maxillomandibular position of minimal nociceptive input is maintained by the bio-facilitation mouthpiece when the user wears the bio-facilitation mouthpiece.
 17. The method of claim 16, wherein identifying a user's unique maxillomandibular position of minimal nociceptive input utilizes manual muscle testing.
 18. The method of claim 16, wherein identifying a user's unique maxillomandibular position of minimal nociceptive input includes: inserting a center portion of a first bite member with a first thickness between the upper and lower anterior teeth of a user while conducting manual muscle testing such that the user's optimal vertical, lateral, and protrusive maxillomandibular position is recorded relative to the first bite member; and inserting a center portion of a second bite member with a second thickness between the upper and lower anterior teeth of a user while conducting manual muscle testing such that the user's optimal vertical, lateral, and protrusive maxillomandibular position is recorded relative to the first bite member, wherein the second thickness is different than the first thickness.
 19. The method of claim 16, wherein creating an impression of a portion of the user's upper and lower anterior teeth in the maxillomandibular position of minimal nociceptive input in the first material includes submerging the first material in water at a temperature that is above the melting temperature of the first material but is below the melting temperature of the second material.
 20. The method of claim 16, wherein the temperature of the water is between about 150° F. and about 200° F. 